Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study

Sponsor
University of Sao Paulo
Study ID
NCT02308644
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab injections associated with standard metabolic control in eyes with diabetic macular edema (DME) associated with standard metabolic control.

Key Dates

First listed
Dec 4, 2014
Start date
Feb 28, 2009
Status verified
Dec 2014
Primary completion
Dec 31, 2011
Completion
Feb 28, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Group 1 - 21 eyes treated with intravitreal bevacizumab injection (1.25mg) at the weeks 0, 6,12 and 18 plus standard metabolic control with glycated hemoglobin measured at baseline, week 12 and 18. All patients were followed by expert (endocrinologist)
  • Sham Comparator: Sham
    Group 2 - 20 eyes treated with sham injection at weeks 0 and 6; and intravitreal bevacizumab injection(1.25mg) in the weeks 12 and 18 plus standard metabolic control with glycated hemoglobin measured at baseline, week 12 and 18. All patients were followed by expert (endocrinologist)

Primary Outcome Measure

Contrast sensitivity [ Time Frame: 6 months (24 weeks ) ]

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